Michael Barbella, Managing Editor04.30.21
It’s not over just yet.
Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products.
The U.S. Environmental Protection Agency (EPA) is expected to issue a final federal rule this year limiting EO emissions from commercial medtech sterilization plants. Considered a carcinogen, EO has been used for decades to clean medical equipment—from plastic tubing and surgical instruments to hospital gowns and artificial joints. Industry experts estimate the chemical is used to sterilize roughly half of all medical equipment, as it can efficiently kill germs without harming materials.
EO’s link to various cancers and physical ailments have spawned a slew of legal action against companies that operate sterilization facilities. Sterigenics closed its plant two years ago in Willowbrook, Ill., by order of that state’s Environmental Protection Agency, and then shuttered another in Georgia in August 2019 following an investigation by the Georgia Environmental Protection Division.
The shutdowns disrupted the medical device supply chain, prompting the U.S. Food and Drug Administration (FDA) to form a task force on EO sterilization. The agency also launched an “innovation challenge” in July 2019 to develop alternatives to EO sterilization and reduce ethylene oxide emissions to “as close to zero as possible.”
Meanwhile, the EPA earlier this year determined that community-specific warnings about EO risks do not have to be made immediately. The agency—still working on the final federal rule—has committed to notifying communities about EO risks by May 31 and has posted status reports on 25 facilities previously identified as high-risk based on known EO emissions and facility location.
Orthopedic Design & Technology’s January/February feature, “The Total Package,” examines the EO- and pandemic-induced challenges and changes facing packaging and sterilization companies. Don Tumminelli, senior technical manager, Client Services, at HIGHPOWER Validation Testing & Lab Services, was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Don Tumminelli: In the world of packaging and sterilization of medical devices, the packaging will depend on whether it is a single-use device sterilized either by a contract sterilizer or a reusable device sterilized at the healthcare facility after subsequent usage. Each has very unique and specific requirements with the common factor being that the packaging will need to be a sterile barrier regardless. For single-use devices, the big trend now is finding ways and materials that could allow less residual ethylene oxide (EtO) in response to the recent developments in the use of large-scale EtO sterilization facilities. For reusable devices, the big trend is with flexible sterilization wrap manufactures all competing with more innovative and user friendly ways of being able to visually detect a compromised package before use. For instance, some have developed separate colors of wrap (for the standard two-layer wrapped devices) that allow for the outer warp and inner warp to have a high contrast, which will allow for better visualization of a rip/hole and tear that may be present. Others are working to minimize and optimize dry times. In this completive industry of sterilization packaging systems, new products will continue to be developed.
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Tumminelli: Reusable wrappers are being designed to minimize and optimize dry times of heavier sets; single-use devices, once again, are being reconsidered for possible repackaging in materials that harbor less EtO residuals.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Tumminelli: It is critical in the early stages to make sure that the packaging is first compatible with the required sterilization process chosen. Not all materials are compatible with each sterilization modality. Also, the durability of the packaging material must be considered, especially for reusable devices that may be shipped around the world. A transpiration study must take in to account shipping, dropping, pressure differentials in air transpiration, temperature variations, stacking, and pallet loading.
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Tumminelli: Employee safety was number one. New protocols for movement around the company, employee spacing, along with allowing those who could work remotely to do so. Lessons learned are that all it takes is one employee who could have been infected to infect others and create a possible company shutdown. Fortunately to date, the company has not experienced this and the policies appear to be working as expected.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Tumminelli: Expanding capacity and staff to make up for employee absences.
Barbella: COVID-19 has somewhat doused the controversy surrounding EtO health/environmental risk factors. Has the technology redeemed itself in light of skyrocketing demand for PPE, or is it just on the back burner for now? Will the debate resume once the pandemic is under control?
Tumminelli: Great question and yes, I believe this is just on hiatus until the smoke clears on COVID-19. I believe the EtO conversations will continue, but at this time is just not as high a priority as it was a year ago,
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
Tumminelli: At this time there are many companies pursuing alternative modalities to EtO and following through with the FDA's innovation challenge. This is going to take some time but I believe vaporized H202 may come out as one of the alternatives. I do not believe it will be able to compete with the high volume and economic advantages of EtO right out the gate, but as like any other new industry will evolve over time to be a major player.
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Tumminelli: I an unaware of any major changes at this time. Many single-use PPE devices have been validated for reuse in standard packaging already commercially available such as pouches and wraps.
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Tumminelli: I do not think we will see any major changes but I do believe we will be seeing more reusable wrappers developed and used in healthcare in order to minimize the amount of waste with single-use wrappers.
Eclipsed for the past year by COVID-19, medtech’s long-simmering ethylene oxide (EO) controversy could soon flare up (again) as the industry grapples with alternative sterilization methods for its products.
The U.S. Environmental Protection Agency (EPA) is expected to issue a final federal rule this year limiting EO emissions from commercial medtech sterilization plants. Considered a carcinogen, EO has been used for decades to clean medical equipment—from plastic tubing and surgical instruments to hospital gowns and artificial joints. Industry experts estimate the chemical is used to sterilize roughly half of all medical equipment, as it can efficiently kill germs without harming materials.
EO’s link to various cancers and physical ailments have spawned a slew of legal action against companies that operate sterilization facilities. Sterigenics closed its plant two years ago in Willowbrook, Ill., by order of that state’s Environmental Protection Agency, and then shuttered another in Georgia in August 2019 following an investigation by the Georgia Environmental Protection Division.
The shutdowns disrupted the medical device supply chain, prompting the U.S. Food and Drug Administration (FDA) to form a task force on EO sterilization. The agency also launched an “innovation challenge” in July 2019 to develop alternatives to EO sterilization and reduce ethylene oxide emissions to “as close to zero as possible.”
Meanwhile, the EPA earlier this year determined that community-specific warnings about EO risks do not have to be made immediately. The agency—still working on the final federal rule—has committed to notifying communities about EO risks by May 31 and has posted status reports on 25 facilities previously identified as high-risk based on known EO emissions and facility location.
Orthopedic Design & Technology’s January/February feature, “The Total Package,” examines the EO- and pandemic-induced challenges and changes facing packaging and sterilization companies. Don Tumminelli, senior technical manager, Client Services, at HIGHPOWER Validation Testing & Lab Services, was among the experts interviewed for the story. His full input is provided in the following Q&A.
Michael Barbella: Please discuss the trends in packaging/sterilization services.
Don Tumminelli: In the world of packaging and sterilization of medical devices, the packaging will depend on whether it is a single-use device sterilized either by a contract sterilizer or a reusable device sterilized at the healthcare facility after subsequent usage. Each has very unique and specific requirements with the common factor being that the packaging will need to be a sterile barrier regardless. For single-use devices, the big trend now is finding ways and materials that could allow less residual ethylene oxide (EtO) in response to the recent developments in the use of large-scale EtO sterilization facilities. For reusable devices, the big trend is with flexible sterilization wrap manufactures all competing with more innovative and user friendly ways of being able to visually detect a compromised package before use. For instance, some have developed separate colors of wrap (for the standard two-layer wrapped devices) that allow for the outer warp and inner warp to have a high contrast, which will allow for better visualization of a rip/hole and tear that may be present. Others are working to minimize and optimize dry times. In this completive industry of sterilization packaging systems, new products will continue to be developed.
Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Tumminelli: Reusable wrappers are being designed to minimize and optimize dry times of heavier sets; single-use devices, once again, are being reconsidered for possible repackaging in materials that harbor less EtO residuals.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Tumminelli: It is critical in the early stages to make sure that the packaging is first compatible with the required sterilization process chosen. Not all materials are compatible with each sterilization modality. Also, the durability of the packaging material must be considered, especially for reusable devices that may be shipped around the world. A transpiration study must take in to account shipping, dropping, pressure differentials in air transpiration, temperature variations, stacking, and pallet loading.
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Tumminelli: Employee safety was number one. New protocols for movement around the company, employee spacing, along with allowing those who could work remotely to do so. Lessons learned are that all it takes is one employee who could have been infected to infect others and create a possible company shutdown. Fortunately to date, the company has not experienced this and the policies appear to be working as expected.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Tumminelli: Expanding capacity and staff to make up for employee absences.
Barbella: COVID-19 has somewhat doused the controversy surrounding EtO health/environmental risk factors. Has the technology redeemed itself in light of skyrocketing demand for PPE, or is it just on the back burner for now? Will the debate resume once the pandemic is under control?
Tumminelli: Great question and yes, I believe this is just on hiatus until the smoke clears on COVID-19. I believe the EtO conversations will continue, but at this time is just not as high a priority as it was a year ago,
Barbella: Are there alternative sterilization methods being developed or available that can replace EtO with respect to scalability and material compatibility?
Tumminelli: At this time there are many companies pursuing alternative modalities to EtO and following through with the FDA's innovation challenge. This is going to take some time but I believe vaporized H202 may come out as one of the alternatives. I do not believe it will be able to compete with the high volume and economic advantages of EtO right out the gate, but as like any other new industry will evolve over time to be a major player.
Barbella: How has the COVID-19 pandemic changed the packaging/sterilization industry (if at all)? Will these changes be permanent?
Tumminelli: I an unaware of any major changes at this time. Many single-use PPE devices have been validated for reuse in standard packaging already commercially available such as pouches and wraps.
Barbella: Where do you see the packaging/sterilization industry headed in five years?
Tumminelli: I do not think we will see any major changes but I do believe we will be seeing more reusable wrappers developed and used in healthcare in order to minimize the amount of waste with single-use wrappers.